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Ethylene Oxide Gamma Electron Beam X-ray Methodology Penetration of sterilant gas into packaged product Irradiation of product using photons from radioisotope Product sterilized using ionizing energy from electron beam Products sterilized using ionizing energy from Rhodotron electron beam Efficacy Process efficacy confirmed by biological indicators and/or process monitoring Process parameters confirmed by dosimetry Process parameters confirmed by dosimetry Process parameters confirmed by dosimetry Penetration Requires gas permeable packaging and product design Good penetration complete even at high densities (> 0.4 gm/cc) Efficient penetration at bulk densities between 0.05 – 0.30 gm/cc Excellent penetration for all product types Material Compatibility Very few material compatibility concerns Liquids are generally not recommended Compatible with most materials; plastics need to be evaluated Avoid acetals, PTFE (teflon), unstable polypropylene Additives are available to correct issues. Negative effects are frequently less pronounced or eliminated Similar to gamma, however negative effects are frequently less pronounced or eliminated Turnaround Time Days: Conventional = 9-10 days. EOExpress® = one day Hours: time varies based on dose requirements Minutes: time varies based on dose requirements Hours: time varies based on dose requirements Process Complex process: Variables include exposure time, temperature, humidity and EO concentration Non-process variables impacting lethality include load density, packaging, and winter shipping conditions. Simple process: Variables include time in the cell and isotope load Complex process: Variables include scan height, processing speed, number of passes, and orientation to the beam Moderately complex process: Variables include processing speed, number of passes and number of pallets on conveyor Product Handling Traditional processing: pallets are transferred between stages via fork truck or conveyor system EOExpress® processing: entire process takes place in the sterilization chamber Aluminum totes/pallets with product placed in pre-determined loading pattern Aluminum carriers with product placed in pre-determined loading pattern, or boxes placed directly onto conveyor Products processed via pallets, in pre- determined loading pattern TECHNICAL TIP FOR MORE INFORMATION STERIS Applied Sterilization Technologies Web: www.steris-ast.com // Email: [email protected] (EMEAA) +44 (0) 8456 88 99 70 (Americas) 877.783.7479 OVERVIEW OF STERILIZATION TECHNOLOGY COMPARISON TechTip #58 | Rev 1, 01/2020

Overview of Sterilization Technology Comparison - STERIS AST

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Page 1: Overview of Sterilization Technology Comparison - STERIS AST

Ethylene Oxide Gamma Electron Beam X-ray

Methodology

Penetration of sterilant gas into

packaged product Irradiation of product using

photons from radioisotope

Product sterilized using

ionizing energy from electron

beam

Products sterilized using

ionizing energy from

Rhodotron electron beam

Efficacy

Process efficacy confirmed by

biological indicators and/or

process monitoring

Process parameters confirmed by

dosimetry

Process parameters confirmed

by dosimetry

Process parameters

confirmed by

dosimetry

Penetration Requires gas permeable packaging

and product design

Good penetration complete even

at high densities (> 0.4 gm/cc)

Efficient penetration at bulk

densities between 0.05 – 0.30

gm/cc

Excellent penetration

for all product types

Material

Compatibility

Very few material compatibility

concerns Liquids are generally not

recommended

Compatible with most materials;

plastics need to be evaluated

Avoid acetals, PTFE (teflon),

unstable polypropylene Additives

are available to correct issues.

Negative effects are frequently

less pronounced or eliminated

Similar to gamma,

however negative

effects are frequently

less pronounced or

eliminated

Turnaround

Time

Days: Conventional = 9-10 days.

EOExpress® = one day

Hours: time varies based on dose

requirements

Minutes: time varies based on

dose requirements

Hours: time varies

based on dose

requirements

Process

Complex process: Variables include

exposure time, temperature,

humidity and EO concentration

Non-process variables impacting

lethality include load density, packaging,

and winter shipping conditions.

Simple process: Variables include

time in the cell and isotope load

Complex process: Variables

include scan height,

processing speed, number of

passes, and orientation to the

beam

Moderately complex

process: Variables

include processing

speed, number of

passes and number of

pallets on conveyor

Product

Handling

Traditional processing: pallets are

transferred between stages via fork

truck or conveyor system

EOExpress® processing: entire

process takes place in the

sterilization chamber

Aluminum totes/pallets with

product placed in pre-determined

loading pattern

Aluminum carriers with product

placed in pre-determined

loading pattern, or boxes

placed directly onto conveyor

Products processed

via pallets, in pre-

determined loading

pattern

T E C H N I C A L T I P

F O R M O R E I N F O R M A T I O N

STERIS Applied Sterilization Technologies

Web: www.steris-ast.com // Email: [email protected]

(EMEAA) +44 (0) 8456 88 99 70

(Americas) 877.783.7479

O V E R V I E W O F S T E R I L I Z A T I O N T E C H N O L O G Y C O M P A R I S O N

TechTip #58 | Rev 1, 01/2020